In recent years, regulatory and law enforcement authorities responsible
for combating fraud and abuse have focused greater attention on the scientific
research process, in particular, the process of seeking reimbursement for
research costs, the process of performing clinical research, and the potential
improper remuneration of researchers or research subjects. This article describes
how the federal False Claims Act, which allows the government to recover treble
damages plus substantial penalties from persons who knowingly submit false
claims or make false statements to the government, has been used to achieve
a number of multimillion-dollar settlements with research institutions. The
article also discusses instances of temporary suspension of research activities
at a number of prominent institutions and the investigation of illegal "inducements"
or "kickbacks" provided by manufacturers to researchers and by research institutions
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The Rational Clinical Examination
The criteria for valid consent to medical treatment vary from state to state but are based on...
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